SALINE NEBULISER SOLUTION (SODIUM CHLORIDE 0.9% W/V)

Transcript

PACKAGE LEAFLET: INFORMATION FOR THE USER

Saline Nebuliser Solution
Sodium chloride 0.9 % w/v
Read all of this leaflet carefully before you start using this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Saline Nebuliser Solution is and what it is used for
2. Before you use Saline Nebuliser Solution
3. How to use Saline Nebuliser Solution
4. Possible side effects
5. How to store Saline Nebuliser Solution
6. Further information
1. WHAT SALINE NEBULISER SOLUTION IS AND WHAT IT IS USED
FOR
Saline Nebuliser Solution is a solution of sodium chloride, that is, salt
water. It is used to dilute medicines that are used in your nebuliser.
Remember, you should also read the leaflet for these medicines before
diluting them with Saline Nebuliser Solution.

2. BEFORE YOU USE SALINE NEBULISER SOLUTION
Saline Nebuliser Solution should only be used in your nebuliser and
following the directions of your doctor.
Do not swallow Saline Nebuliser Solution. The solution should never be
given by injection.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, talk to your doctor before using this
medicine.
Important information about some of the ingredients of
Saline Nebuliser Solution
This medicinal product is a solution of salt and this needs to be taken
into consideration by patients on a controlled sodium (salt) diet.

3. HOW TO USE SALINE NEBULISER SOLUTION
Always use Saline Nebuliser Solution exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are not sure.
You must only use Saline Nebuliser Solution in a nebuliser. The nebuliser
turns the solution into a fine mist which you can breathe in. Always read
the manufacturer’s instructions and make sure you know how to use the
nebuliser before you take your medicine.
1. Prepare your nebuliser for use according to the instructions provided
by the manufacturer and the advice given by your doctor.
2. The nebulised product that you will dilute should be placed into the
nebuliser chamber as instructed in the patient information leaflet of
that product.
3. Carefully remove an ampoule of Saline
Nebuliser Solution from the labelled strip
1 DETACH
HERE
by twisting and pulling (diagram 1). Never
use an ampoule that has already been
opened.

4. Open the ampoule by twisting off the top,
2
taking care to hold it in an upright position
TWIST
(diagram 2).
5. Squeeze the contents of the ampoule (or
dosing syringe if you are using one) into
the nebuliser chamber and swirl the
contents of the nebuliser gently to mix.
6. U
se your nebuliser according to the
Diagram 2
manufacturer’s instructions and as advised
by your doctor.
7. A
fter you have used your nebuliser, throw away any solution that is
left in the reservoir.
8. C
lean your nebuliser thoroughly according to the manufacturer’s
instructions.
As there are no preservatives in Saline Nebuliser Solution, it is important
that you use the contents of the ampoule immediately after opening and
that you mix up a fresh batch of the solution before each dose. Discard
any partly used, opened or damaged ampoules and any solution
remaining in the nebuliser chamber after use.
Do not swallow the solution or use it in injections.
Follow your doctor’s instructions when you are diluting medicines for use
in your nebuliser and refer to the patient information leaflet of the
product to be diluted for more detailed instructions on using saline
solution for dilution.
If you are using your nebuliser solutions at home, and you find that you
are not getting your usual amount of relief or the relief does not last as
long, consult with your doctor.
If you use more Saline Nebuliser Solution than you think you
should or accidently swallow it: Contact your doctor or hospital
immediately. Take any remaining solution or this leaflet with you so the
medical staff know exactly what you have taken.

Diagram 1

colours/plates:

Sodium Chloride 0.9% PIL - UK (Arrow)

1. Black

item no: AAAH2776

dimensions: 200 x 280

print proof no: 2

pharmacode:

origination date: 23.09.14

min pt size: 8pt

3.
4.
5.
6.

originated by: dje
approved for print/date

2.

revision date: 24.09.14

Technical Approval

revised by: dje

date sent: 23.09.14

supplier: Laboratoire Unither

technically app. date: 24.09.14

Non Printing Colours
1.
2.
3.

4. POSSIBLE SIDE EFFECTS
It is unlikely that Saline Nebuliser Solution will cause any side effects.
However, if you think you may have developed a side effect please tell
your doctor or pharmacist.
The medicine you breathe in with Saline Nebuliser Solution could cause
some side effects. The leaflet that comes with that medicine will give
you more information on this.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. You can also report side
effects directly via Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
By reporting side affects you can help provide more information on the
safety of this medicine.
5. HOW TO STORE SALINE NEBULISER SOLUTION
Keep out of the reach and sight of children.
Do not store above 25°C. Do not refrigerate or freeze.
Do not use this medicine if the solution is cloudy or after the expiry date
as stated on the carton.
The expiry date refers to the last day of that month.
Ampoules removed from the foil overwrap should be used within 90 days.
Use the solution immediately after first opening the ampoule.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.
6. FURTHER INFORMATION
What Saline Nebuliser Solution contains
- The active substance is sodium chloride 0.9% w/v. Each 1 ml of solution
contains 9 mg of sodium chloride.
- The other ingredient is Water for Injections.
What Saline Nebuliser Solution looks like and contents of the
pack
Saline Nebuliser Solution is supplied as a unit dose blow moulded
hermetically sealed plastic ampoule containing 2.5 ml of solution.
Strips of ten ampoules are overwrapped in an aluminium laminate foil
pack.
Saline Nebuliser Solution is available in boxes containing 20, 60 or 100
ampoules.
Marketing Authorisation Holder: Breath Limited,
Whiddon Valley, Barnstaple, North Devon, EX32 8NS, United Kingdom.
Manufacturer: Laboratoire Unither
Espace lndustriel Nord, 151 rue Andre Durouchez - CS 28028,
80084 AMIENS CEDEX 2, France.
This leaflet was last revised in September 2014

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.